Z-2336-2021 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- September 1, 2021
- Initiation Date
- June 25, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
KeyPrint Soft- bottle, 32.5 oz (1kg). Resin for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints and repositioners. Model (Ref) #: 4220005
Reason for Recall
Product label intended for the European community was distributed to the USA market via their US distribution organization
Distribution Pattern
US Nationwide distribution in the state of TX.
Code Information
Lot Number: KJ2858 Shelf Life (Expiration Date): 22 April 2023 Unique Device Identifier (UDI): +H66842200051/$$3230422KJ2858U